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CFSAN/Office of Premarket Approval
January 29, 1999
Ms. Kaarina Taimisto
Rohm Enzyme Finland Oy
Re: GRAS Notice No. GRN 000010
Dear Ms. Taimisto:
The Food and Drug Administration (FDA) is responding to your notice, dated October 16, 1998, that you submitted in accordance with the agency's proposed regulation, proposed 21 CFR 170.36 (62 FR 18938; April 17, 1997; Substances Generally Recognized as Safe (GRAS)). FDA received your notice on October 28, 1998 and designated your notice as GRAS Notice No. GRN 000010. Your notice states that Rohm Enzyme Finland Oy (Rohm) has determined that the exopeptidase enzyme preparation COROLASE LAP, which is derived from a strain of Aspergillus oryzae that carries the gene for a leucine aminopeptidase enzyme derived from Aspergillus sojae, is generally recognized as safe (GRAS) for use as a processing aid at a use level ranging from 0.02% to 0.8% of a food product or ingredient.
In the GRAS proposal, FDA proposed to establish a procedure whereby any person may notify FDA of a determination that a particular use of a substance is GRAS. Such notice to FDA is a voluntary mechanism for communication between a person who determines that a use of a substance is exempt from the statutory premarket approval requirements and FDA, the federal agency responsible for implementing those statutory provisions. A threshold question for such a notice is whether the particular use of a substance satisfies the GRAS criteria, which are described in § 170.30. As discussed in the GRAS proposal, FDA would evaluate whether a submitted notice provides a sufficient basis for a GRAS determination and whether information in the notice or otherwise available to FDA raises questions as to whether use of the substance is GRAS. Proposed § 170.36(c) describes in detail the information that FDA considers important in evaluating whether a notice provides a sufficient basis for a GRAS determination.
Your notice consists of a brief letter and a report (the GRAS Panel report) claimed to have been prepared by an assembled panel of experts in the area of food safety. This notice lacks much of the information described in proposed § 170.36. Accordingly, your notice, in its present form, does not provide a sufficient basis for a determination that the subject use of the exopeptidase enzyme preparation COROLASE LAP is GRAS.
For example, your notice does not state whether the basis for the GRAS determination is through scientific procedures or through experience based on common use in food (proposed § 170.36(c)(1)(iv)). In addition, your notice does not include certain information regarding the conditions of use of the enzyme preparation, i.e., the foods in which the enzyme preparation will be used (proposed § 170.36(c)(1)(iii)). Further, your notice lacks detailed information about the identity of the enzyme and the enzyme preparation, including the enzyme's Enzyme Commission number and the method of manufacture (proposed § 170.36(c)(2)). Importantly, your notice does not include any citations to generally available data, information, methods or principles that you relied on to determine safety (proposed § 170.36(c)(4)). In light of all these omissions, your notice cannot provide a sufficient basis for a GRAS determination.
In addition, your notice is not complete from an administrative perspective. Under proposed § 170.36(c)(1)(v), you must date and sign a statement that the data and information that are the basis for your GRAS determination are available for FDA review and copying (e.g., if we visited your place of business) or will be sent to FDA upon request.
If you have any questions regarding the proposed GRAS notification program, you may contact Dr. Linda Kahl by telephone at (202)418-3101 or by telefax at (202)418-3131. Dr. Kahl may also be reached through electronic mail sent to LKAHL@BANGATE.FDA.GOV. To assist you in preparing a notice that contains the necessary information, we have enclosed a copy of the GRAS proposal. We also have enclosed a copy of a document entitled "Enzyme Preparations: Chemistry Recommendations for Food Additive and GRAS Affirmation Petitions." Although this document was developed as guidance for the submission of a food additive or GRAS petition, it contains useful information that can be generally applied to the safety evaluation of any enzyme preparation.
In accordance with proposed 21 CFR 170.36(f), a copy of this letter, as well as a copy of the information in your notice that conforms to the information described in proposed § 170.36(c)(1), is available for public review and copying in the public reading room of the agency's Freedom of Information Staff.
Alan M. Rulis, Ph.D.
Office of Premarket Approval
Center for Food Safety and Applied Nutrition
Enzyme Preparations: Chemistry Recommendations